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The MANTIS™ Spinal System is intended for percutaneous, posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

The MANTIS™ Spinal System includes cannulated polyaxial screw and straight or pre-bent rod components that can be used via a percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile.

The provided text is a 510(k) Summary for the MANTIS™ Spinal System, a medical device for spinal fixation. It details the device's description, intended use, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving device performance against such criteria in the context of the requested AI/algorithm evaluation.

The 510(k) process for this type of medical device (spinal fixation system) typically involves demonstrating substantial equivalence to a legally marketed predicate device through engineering tests (e.g., mechanical strength, fatigue, biocompatibility) rather than clinical studies of "acceptance criteria" or "device performance" as understood in algorithm evaluation (like sensitivity, specificity, or reader studies).

Therefore, I cannot provide the requested information from the provided document.

To be explicit, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) focuses on substantial equivalence to predicate devices, not specific performance metrics against pre-defined acceptance criteria, especially not in an AI/algorithm context.
2. Sample sized used for the test set and the data provenance: Not applicable/not present. No "test set" for an algorithm is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method: Not applicable/not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This document describes a physical medical device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
7. The type of ground truth used: Not applicable/not present.
8. The sample size for the training set: Not applicable/not present.
9. How the ground truth for the training set was established: Not applicable/not present.

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